Transfemoral TAVI With or Without Coronary Angiogram in Patients With Severe Aortic Stenosis (PURE TAVI)

NCT06898086 | Recruiting DMC

• 1 other identifier: RO-240905
• Study Type: interventional
• Target: 620
• Locations: 7 countries
• Sites: 23

Brief Summary

This study will be conducted in patients with severe aortic stenosis who are referred for transcatheter aortic valve implantation (TAVI). TAVI is the recommended treatment for severe aortic stenosis. Currently, before undergoing TAVI, most patients undergo a coronary angiography to check whether the coronary arteries are blocked and to assist in appropriate valve sizing. If significant blockages are detected, they are treated before or during TAVI. However, many patients who undergo TAVI are older and often have additional cardiovascular conditions such as hypertension, diabetes, or obesity. These comorbidities increase the risk of complications related to coronary angiography, including kidney injury from contrast dye, bleeding, and vascular complications at the access site. As such, it remains uncertain whether routine coronary angiography is necessary for all patients undergoing TAVI, particularly those without symptoms suggestive of myocardial ischemia. This study aims to determine whether a TAVI treatment pathway without prior coronary angiography is non-inferior to the standard pathway that includes routine coronary angiography, with or without revascularization, in patients with severe aortic stenosis who do not have typical angina symptoms (defined as Canadian Cardiovascular Society Class \<3). "Non-inferior" means the study seeks to show that omitting routine coronary angiography is at least as effective and safe as the standard approach. All participants will receive a CE-certified Myval™ balloon-expandable transcatheter heart valve. This device is commercially available and designed to provide accurate positioning and reliable valve function. This is a multicentre, investigator-initiated clinical study sponsored by Rede Optimus (RO), Alte Steinhauserstrasse 1, 6330 Cham, Switzerland. RO conducts independent research to address unresolved questions in vascular medicine. The study is financially supported by Meril Life Sciences Pvt. Ltd., Bilakhia House, Survey No.135/139, Muktanand Marg, Chala, Vapi 396191, Gujarat, India. Approximately 620 patients will be enrolled across 20 centres in 7 European countries. The total study duration is expected to be 42 months, with an 18-month enrollment period and 24-month follow-up for each participant.

Conditions

Severe Aortic Stenosis

Keywords

PURE TAVI

Outcome Measures

Primary Outcomes (1)

• Composite of all-cause death, spontaneous or periprocedural myocardial infarction, etc

  Composite of all-cause death, spontaneous or periprocedural myocardial infarction, urgent revascularization during unplanned hospitalization, readmission for heart failure, acute renal injury, major or life-threatening or disabling bleeding, major vascular complication, or any stroke at 12-months follow-up

  at 12-months follow-up

Study Arms (2)

Experimental group

EXPERIMENTAL

(omission of coronary angiography prior to or during TAVI, unless suspicion of potentially revascularization-indicating stenosis of the left main stem based on the TAVI-CT);

Device: Transcatheter aortic valve implantation

Control group

ACTIVE COMPARATOR

(coronary angiography with or without PCI prior to TAVI).

Device: Transcatheter aortic valve implantation

Interventions

Transcatheter aortic valve implantation DEVICE

Transcatheter aortic valve implantation using the CE-certified Myval™ transcatheter heart valve series

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is older than 18 years with severe AS considered for TAVI by a multidisciplinary heart team.
• Patient is candidate for transfemoral TAVI as per local standards and current guidelines.
• Patient is willing and capable to give written consent to participate to the trial and confirmed to be able to attend the expected follow up visits.

You may not qualify if:

• Patient had a coronary angiogram with or without PCI and/or coronary CT and/or CABG within last 5 years.
• Left main PCI in the medical history
• Patient has CCS of 3 or more.
• Patient has left ventricular ejection fraction \<30%.
• Patients in whom TAVI through femoral access is ad priori not possible based on clinical assessment or medical history
• Patient has been treated for acute myocardial infarction within 30 days before randomization.
• Patient has a planned open-heart surgery.
• Patient has a life expectancy less than 1 year due to other severe non-cardiac disease.
• Patient is participating in another clinical study with an investigational product that has not yet completed the follow up period.
• Patient has received previous treatment for aortic valve implantation or replacement.

Sponsors & Collaborators

• Rede Optimus Hospitalar SA: lead

Study Sites (23)

Medical University Graz

Graz, 8036, Austria

RECRUITING

Klinikum Klagenfurt am Wörthersee

Klagenfurt, 9020, Austria

NOT YET RECRUITING

Královské Vinohrady University Hospital

Prague, 10034, Czechia

NOT YET RECRUITING

Nemocnice Na Homolce

Prague, 15030, Czechia

NOT YET RECRUITING

Institut Arnault Tzanck

Nice, 06700, France

NOT YET RECRUITING

Clinique Pasteur

Toulouse, 31076, France

NOT YET RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40221, Germany

NOT YET RECRUITING

Elisabeth Krankenhaus Essen

Essen, 45138, Germany

NOT YET RECRUITING

Universitätsklinikum Freiburg- Universitäts-Herzzentrum Campus Bad Krozingen

Freiburg im Breisgau, 79189, Germany

NOT YET RECRUITING

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, 23562, Germany

NOT YET RECRUITING

Universitätsklinikum Ulm

Ulm, 89081, Germany

NOT YET RECRUITING

IRCCS ISMETT Palermo

Palermo, Basel-Stadt, 90127, Italy

NOT YET RECRUITING

AOUP- Azienda Ospedaliera Universitaria Pisana

Pisa, Basel-Stadt, 56126, Italy

NOT YET RECRUITING

Azienda Ospedaliero Policlinico Universitaria G. Rodolico- San Marco Catania

Catania, 95123, Italy

NOT YET RECRUITING

Ospedale dell'Angelo - ULSS 3 Serenissima

Mestre, 30174, Italy

NOT YET RECRUITING

Fondazione Policlinico Universitario Campus Biomedico

Roma, 00128, Italy

RECRUITING

Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

NOT YET RECRUITING

Azienda Sanitaria Universitaria Integrata di Trieste

Trieste, 34128, Italy

NOT YET RECRUITING

Stichting Amsterdam UMC

Amsterdam, 1081, Netherlands

NOT YET RECRUITING

OLVG Hospital Amsterdam

Amsterdam, 1091, Netherlands

NOT YET RECRUITING

Clinical Trial Center Maastricht B.V

Maastricht, 6229, Netherlands

NOT YET RECRUITING

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

RECRUITING

University Hospital Zurich

Zurich, 8091, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Dr. William Wijns, Professor

  STUDY CHAIR

• Dr. Gabor G Toth, Professor

  STUDY CHAIR

• Dr. Felix Mahfoud, Professor

  STUDY CHAIR

• Flavio Ribichini, Professor

  STUDY CHAIR

• Dr. Emanuele Barbato, Professor

  STUDY CHAIR

• Dr. Peter Jüni, Professor

  STUDY CHAIR

Central Study Contacts

Julie Bosiers

CONTACT

+32 479 64 37 60; julie.bosiers@redeoptimus.com

Gavin Vaz

CONTACT

04917615203936; gavin.vaz@redeoptimus.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label trial. Neither participants nor clinicians are masked to the treatment allocation because the performance of coronary angiography cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned in a 1:1 ratio to a TAVI pathway with routine coronary angiography with or without revascularization is included or to a pathway without routine coronary angiography, and both groups are followed in parallel.

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 27, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2028
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

CH (2); FR (2); CZ (2); DE (5); NL (3); AU (2); IT (7)